Trials / Completed
CompletedNCT03263260
Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent
Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,504 (actual)
- Sponsor
- Scitech Produtos Medicos SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.
Detailed description
Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent. Stent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure. Patients will be followed at 30 days, 1 and 2 years after procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | implant | coronary stent implantation |
Timeline
- Start date
- 2017-06-02
- Primary completion
- 2022-12-15
- Completion
- 2024-01-21
- First posted
- 2017-08-28
- Last updated
- 2024-09-04
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03263260. Inclusion in this directory is not an endorsement.